A study to determine the appropriate dose(s) of Dupilumab (REGN668)in adult patients with moderate to severe atopic dermatitis (eczema)

Conditions: Atopic dermatits
MedDRA version: 16.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2012-003651-11-PL

Lead Sponsor: Regeneron Pharmaceuticals, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 240

Inclusion Criteria

1. Adult patients with moderate to severe atopic dermatitis whose disease cannot be adequately controlled with topical medications
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1. Prior treatment with REGN668
2. Recent treatment (within specific time windows before the baseline visit) with systemic corticosteroids, immunosuppressive agents, topical corticosteroids and calcineurin inhibitors, live (attenuated) vaccine, other investigational drugs
3. History of human immunodeficiency virus (HIV) infection
4. HIV or viral hepatitis seropositivity at screening
5. Known or suspected immunosuppresion
6. Recent infections requiring antiinfectious treatment
7. Recent history or high risk of clinical endoparasitoses
8. High risk populations (low life expectancy, severe concomitant diseases, etc.)
9. Pregnant or breast-feeding women
10. Female patients of reproductive potential and sexually active who are unwilling to use adequate contraception

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to assess the efficacy of multiple REGN668 dose-regimens, compared to placebo, in adult patients with moderate-to-severe atopic dermatitis (AD).;Secondary Objective: The secondary objectives of the study are:<br>• To assess the safety of multiple REGN668 dose-regimens, compared to placebo, in adult patients with moderate-to-severe AD<br>• To assess the pharmacokinetics (PK) of multiple REGN668 dose-regimens in adult patients with moderate-to-severe AD<br>• To assess the potential immune response across multiple REGN668 dose-regimens, and to compare to placebo, in adult patients with moderate-to-severe AD<br>;Primary end point(s): The primary endpoint in the study is the percent change in EASI score from baseline to week 16.;Timepoint(s) of evaluation of this end point: Throughout the duration of the study

Secondary Outcome Measures